Investigation of potentially effectiveness of pomegranate husk extract topical gel on wound healing of diabetic foot ulcers: A randomized, parallel controlled phase II clinical trial

Evaluating the effectiveness of topical use of gel containing pomegranate husk extract in healing diabetic foot ulcers

Clinical trial (phase 2) randomized controlled trial (RCT), two parallel groups, diabetic patients with diabetic ulcers in the lower limbs, number of 40 people, allocation ratio 1:1 using randomized block method (block size 4), unilateral blinding, patient follow-up for a maximum of 3 months

Place of study: Imam Reza Hospital of Kermanshah, one-way blinding (only the evaluator). In the control group, the usual wound care from the second day includes washing twice a day with water without betadine along with debridement. In the target group, in addition to the mentioned cases, a topical gel containing pomegranate husk extract (2.5%) is used topically.

Inclusion criteria: Diabetic patients with diabetic ulcers in the lower limbs without more than 50% reduction in the size of the ulcer during the last month. Exclusion criteria: Presence of bone and tendon, abscess with erythema and local sensitivity at the wound site, osteomyelitis, malignancy, use of anti-inflammatory drugs and growth factors in the last 2 weeks and radiotherapy in the last three months, lack of consent to participate in the study

Control group: The usual wound care from the second day includes washing twice a day with water without betadine along with debridement if needed. Target group: In addition to the mentioned cases, topical gel containing pomegranate fruit peel extract (2.5%) is used and routine care is also performed

1) Duration of complete healing of the wound (initial) 2) wound area before intervention and after intervention on days 7, 14, 21, and 30 (secondary)

Randomization will be done by the random block method with a block size of 4. Unlike simple randomization, in which eligible patients are randomly assigned directly to treatments, in randomization with random blocks, patients are randomly assigned to the blocks in a sequence according to the size of the blocks, and finally, in each block of size 4, two patients will be randomly assigned to each intervention. Considering that the size of the blocks is assumed to be 4, there are six random arrangements or modes for the same allocation of patients to two interventions in each block, and this random sequence for the random allocation of patients to interventions in the block will be created by the methodology consultant. The rest of the project colleagues do not have access to the details of the random sequence until after the random allocation of patients.

The blinding will be unilateral, so that the evaluator who will follow the patient will be blinded to the type of intervention.

After patent registering of the study, it will be acted.